2018-20903. Insanitary Conditions at Compounding Facilities; Revised Draft Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice of availability.

SUMMARY:

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled, “Insanitary Conditions at Compounding Facilities.” Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients. FDA is issuing this revised draft guidance to help compounding facilities identify insanitary conditions so that they can implement appropriate corrective actions. This revised draft guidance is also intended to help state regulatory agencies understand some examples of what FDA considers to be insanitary conditions that could cause a drug to become contaminated or rendered injurious to health. This guidance revises the draft guidance entitled “Insanitary Conditions at Compounding Facilities” that was published on August 4, 2016.

DATES:

Submit either electronic or written comments on the draft guidance by November 26, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins works on the final version of the guidance.

ADDRESSES:

You may submit comments on any guidance at any time as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2016-D-2268 for “Insanitary Conditions at Compounding Facilities.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/​fdsys/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).

Submit written requests for single copies of the revised draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the revised draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-3110.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a revised draft guidance for industry entitled “Insanitary Conditions at Compounding Facilities.” Under section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 351(a)(2)(A)), a drug is adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. Drug products compounded under insanitary conditions could become contaminated and cause serious adverse events, including death, in patients. Although sections 503A and 503B of the FD&C Act (21 U.S.C. 353a and 353b) provide exemptions for compounded drugs from specified provisions of the FD&C Act if certain conditions are met, neither section provides an exemption from section 501(a)(2)(A) of the FD&C Act. Any drug that is prepared, packed, or held under insanitary conditions is deemed to be adulterated under the FD&C Act, including drugs produced by a compounding facility.

Since a 2012 fungal meningitis outbreak associated with injectable drug products that a pharmacy compounded and shipped to patients and health care providers across the country, the Agency has identified insanitary conditions at many of the compounding facilities that it has inspected, and numerous compounders have voluntarily recalled drug products intended to be sterile and temporarily or permanently ceased sterile operations because of these findings. FDA does not inspect the vast majority of compounding facilities in the United States because they generally do not register with FDA unless they are outsourcing facilities. Therefore, unless FDA receives a complaint, such as a report of a serious adverse event or visible contamination, the Agency is often not aware of these facilities, their conditions and practices, and potential problems with the quality and safety of their drug products. It is critical that compounding facilities identify and remediate any insanitary conditions at their facilities before the conditions result in drug contamination and patient injury.

In the Federal Register of August 4, 2016 (81 FR 51449), FDA announced the availability of a draft guidance for industry entitled, “Insanitary Conditions at Compounding Facilities.” The draft guidance provided examples of insanitary conditions that the Agency has observed at compounding facilities it has inspected and considers to be insanitary conditions. The draft guidance also described corrective actions that compounding facilities should take when they identify such conditions and the regulatory actions FDA may take in response to identified insanitary conditions. FDA received comments on the draft guidance including feedback from various stakeholders (e.g., physicians, pharmacies), particularly concerning the implications of the policies described in the draft guidance for physicians who prepare drugs in their offices. FDA is revising the draft guidance to address the stakeholders' feedback and to provide further clarification on the insanitary conditions described in the guidance, as well as the actions FDA intends to take with respect to insanitary conditions. FDA is issuing this revised draft guidance to enable the public to further review and comment before finalization of FDA's policies concerning insanitary conditions. We expect that the guidance will help compounding facilities to identify insanitary conditions so that they can implement appropriate corrective actions, and will assist states in identifying insanitary conditions during their inspections of compounding facilities.

This revised draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The revised draft guidance, when finalized, will represent the current thinking of FDA on “Insanitary Conditions at Compounding Facilities.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.

II. Electronic Access

Persons with access to the internet may obtain the revised draft guidance at either https://www.fda.gov/​Drugs/​GuidanceComplianceRegulatoryInformation/​Guidances/​default.htm or https://www.regulations.gov.

Dated: September 20, 2018.

Leslie Kux,

Associate Commissioner for Policy.